What is the European Medicines Agency?
The EMA is Europe’s regulatory agency for medicines and approves new treatments and vaccines for all 27 countries across the European Union. It is roughly comparable to the U.S. Food and Drug Administration. The agency is headquartered in Amsterdam and has nearly 900 employees.
Why does the EMA take so long to approve a vaccine?
The UK, Canada and the US have given approval for the Pfizer-BioNTech vaccine to be used under emergency use provisions earlier this month, meaning the shot is an unlicensed product whose temporary use justifies the urgency of a pandemic that has already killed more than 1 , 6 million people.
But the EMA’s approval process for coronavirus vaccines is largely similar to the standard licensing procedure that would be granted to any new vaccine, only on an accelerated schedule. The companies will still have to send further data to the EU regulator and the approval will have to be renewed after one year.
EMA executive director Emer Cooke told The Associated Press that although all regulatory agencies in the United States, the United Kingdom and Canada mostly look at the same data, “we may not all have gotten it at the same time.” EMA began its rapid approval. process of the Pfizer-BioNTech vaccine in October and the companies formally asked to authorize their firing on December 1st.
Using its rapid approval process, the EMA says the time to evaluate a new drug or vaccine has been shortened from about 210 days to less than 150.
How will the EMA decide whether to improve the vaccine?
The EMA is convening an “extraordinary” meeting on December 29 – although that date could have been raised earlier – during which their experts will discuss the data behind the Pfizer-BioNTech vaccine. The closed meeting will include a presentation. of two officials charged with evaluating the vaccine and could also include importing company representatives to answer questions.
Within hours of the end of the meeting, the EMA will issue a statement on whether or not it recommends the approval of the vaccine. Several days later, they will publish their full scientific assessment explaining the decision.
EMA approval is valid in all 27 EU countries and once it is granted, countries can start receiving vaccines for immunization campaigns. An Italian health official says all EU countries want to start vaccinations on the same day.
What does Germany think?
Germany is stepping up pressure on the agency, with its health minister, top hospital association and lawmakers, all demanding that it approve a vaccine against coronavirus before Christmas. “Our goal is approval before Christmas so we can still get vaccinated this year,” said health minister Jens Spahn. Spahn expressed impatience with the EMA, noting that Germany has already set up about 440 vaccination centers, activated about 10,000 doctors and physicians. staff and was ready to begin mass vaccinations.
The German Hospital Association also exploded on Tuesday, demanding that the agency grant emergency authorization for the Pfizer-BioNTech vaccine. Thus, it says, workers can enter nursing homes to vaccinate those most at risk of dying from the virus. Other EU nations are also getting impatient.
“My hope is that the EMA, in accordance with all safety procedures, will be able to approve the Pfizer-BioNTech vaccine sooner than expected and that vaccinations can also begin in European Union countries as soon as possible,” Italian Health Minister Roberto Hope said Tuesday.
Will the EMA speed up its approval?
Cooke, the agency’s chief executive, said Monday that EMA employees are working “continuously” and that if they have enough data and have completed their required protocols, the Dec. 29 meeting to consider the Pfizer-BioNTech vaccine could indeed to move. “We feel a huge responsibility to do this right … to make sure that what we deliver in terms of scientific opinion is robust and reliable,” Cooke told AP in an interview last week. “It’s already a huge responsibility, I can tell you, without running around it.”
Is the agency examining any other coronavirus vaccines?
The EMA also plans to convene a meeting on January 12 to consider approving the coronavirus vaccine made by Moderna, but said a discussion could also be put forward sooner. It also evaluates data from two other vaccines, one made by Oxford University and AstraZeneca and the other by Janssen, but neither of those two companies has yet made a formal request to be authorized in the EU.
How will EMA ensure that a vaccine is safe after it is used?
The agency usually asks companies to provide data on vaccine safety and side effects every six months, but because of the coronary pandemic, it will ask companies for that data on a monthly basis.
“We need to consider how (these vaccines) work after they have been deployed in a massive vaccine situation,” Cooke said, explaining that the EMA is adopting additional surveillance measures to detect any rare or serious side effects. Although tests by the Pfizer-BioNTech vaccine have suggested that the shot is safe and about 95% effective in preventing COVID-19, there is limited limited long-term safety data on it.